Clinical TrialJun 12, 2026, 07:03 AM
BioCryst reports positive ORLADEYO & navenibart HAE clinical data
AI Summary
BioCryst Pharmaceuticals announced new clinical data and real-world evidence for ORLADEYO and new data from the Phase 1b/2 ALPHA-STAR study of investigational navenibart, both for hereditary angioedema (HAE). The data, to be presented at EAACI, reinforce the strength of BioCryst's HAE portfolio, showing consistent reductions in HAE attack burden and healthcare utilization across diverse patient populations for ORLADEYO, and consistent attack rate reductions for navenibart across patient subgroups, supporting its Phase 3 evaluation.
Key Highlights
- ORLADEYO reduced median HAE attack rate from 0.691 to 0.169 attacks/month in pediatric patients.
- ORLADEYO reduced HAE attacks requiring professional care from 22 to 3 over 12 weeks in pediatric patients.
- Investigational navenibart consistently reduced HAE attack rates across patient subgroups in ALPHA-STAR study.
- Navenibart treatment led to reductions in moderate or severe HAE attacks and on-demand medication use.
- Real-world evidence for ORLADEYO showed sustained reductions in HAE burden and healthcare utilization.
- No significant safety concerns for ORLADEYO over 48 weeks; navenibart was well tolerated.
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